Thermogram No Substitute for Mammogram

Thermography generates an infrared image that shows the patterns of heat and blood flow on or near the surface of the body. The agency has sent several warning letters to health care providers and a thermography manufacturer who claim that the thermal imaging can take the place of mammography.

Websites have been touting thermography as a replacement for mammography, claiming that thermography can find breast cancer years before it would be detected by mammography.

The problem is that FDA has no evidence to support these claims. "Mammography is still the most effective screening method for detecting breast cancer in its early, most treatable stages," said Helen Barr, MD, director of the Division of Mammography Quality and Radiation Programs in the FDA's Center for Devices and Radiological Health. "Women should not rely solely on thermography for the screening or diagnosis of breast cancer. While there is plenty of evidence that mammography is effective in breast cancer detection, there is simply no evidence that thermography can take its place."

Thermography devices have been cleared by the FDA for use as an adjunct or additional tool for detecting breast cancer. Toni Stifano, a consumer safety officer in FDA's Center for Devices and Radiological Health, explains that this means thermography should not be used by itself to screen for or to diagnose breast cancer.

The greatest danger, according to Ms. Stifano, a breast cancer survivor herself, is that patients who substitute thermography for mammography may miss the chance to detect cancer at its earliest stage. There has been a steady decline in breast cancer deaths and one of the reasons is early detection through mammography, according to the FDA. As for concerns about exposure to radiation from a mammogram, evidence shows that the benefits outweigh the risks of harm, especially when compared to the danger of breast cancer.

The FDA is advising patients to continue to have regular mammograms according to screening guidelines or as recommended by their healthcare professional. Patients are also advised to follow their healthcare professional's recommendations for additional diagnostic procedures, such as other mammographic views, clinical breast exam, breast ultrasound, magnetic resonance imaging (MRI) or biopsy. Additional procedures could include thermography.

In 2011 alone, the agency has sent warning letters to practitioners and manufacturer making misleading claims about thermography:

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US Food and Drug Administration